Inhalation device

ABSTRACT

The present invention provides for the integration of drug dispersion methods into a drug or medicine delivery system. The drug dispersion methods used include shear (e.g., air across a drug, with or without a gas assist), capillary flow or a venturi effect, mechanical means such as spinning, vibration, or impaction, and turbulence (e.g., using mesh screens, or restrictions in the air path). These methods of drug dispersion allow for all of the drug in the system to be released, allowing control of the dosage size. These methods also provide for drug metering, fluidization, entrainment, deaggragation and deagglomeration. The present invention also provides for the integration of a drug sealing system into the device. The drug sealing system provides a way of blocking the migration of drug from one area of the package to another. The drug seal system can also provide a method of tightly containing the drug until the package is opened, of directing airflow through the package and of managing and containing the drug during the package/device manufacturing process.

RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.16/859,683 filed Apr. 27, 2020, which is a continuation of Ser. No.14/248,628 filed Apr. 9, 2014, now U.S. Pat. No. 10,632,268 issued Apr.28, 2020; which is a continuation of U.S. patent application Ser. No.11/491,004 filed Jul. 20, 2006, now U.S. Pat. No. 8,763,605 issued Jul.1, 2014; which claims the benefit under 35 U.S.C. 119(e) of the U.S.Provisional Applications Ser. No. 60/734,575, filed Nov. 8, 2005, Ser.No. 60/703,032 filed Jul. 27, 2005, and Ser. No. 60/700,947 filed Jul.20, 2005, each of which is entitled “INHALATION DEVICE” and each ofwhich is incorporated herein by reference.

BACKGROUND OF THE INVENTION

The present invention relates to a system for storing and deliveringsubstances, such as medicines. The present invention is particularlyuseful for the administration of medicine by inhalation.

Various drugs in dry powder form may be inhaled directly into the lungsthrough the mouth or nose. Inhalation allows the drug to bypass thedigestive system and may eliminate the need for other more invasive drugapplication techniques, such as hypodermic injections. Direct inhalationcan also allow smaller doses of a drug to be used to achieve the samedesired results as the same drug taken orally. Inhalation can also helpavoid certain undesirable side effects associated with taking a medicineorally or by injection.

One form of delivery device that is employed for inhaling a drug is thepressurized aerosol or metered dose inhaler (MDI). MDI's are, however,not suitable for use by all patients, e.g., small children, or for theadministration of all medicaments. In addition, MDI's use propellantsthat can cause environmental damage. A widely used alternative is theso-called dry powder inhaler in which medicament powder is dispensedfrom an elongate gelatin capsule by causing the capsule to rotate and/orvibrate in an airstream, releasing the medicament that is inhaled by thepatient. The capsules may be pierced by a suitable puncturing mechanismto release the medicament, or the capsules may be supplied inpre-pierced form. Additional packaging that prevents loss of powder fromthe capsule and the ingress of moisture is often necessary.

Gelatin capsules, and known drug delivery devices for inhalation, sufferfrom numerous disadvantages. For example, gelatin capsules are notimpervious to moisture so exposure to the atmosphere can result inabsorption of moisture. This may lead to agglomeration of the medicamentpowder particles. These problems may be particularly acute where, as isoften the case, the medicament is hygroscopic. As a result, capsulesmust be packaged in secondary packaging such as a blister package, whichsignificantly increases the overall bulk of the device. In addition, thesecondary packaging can be unwieldy or difficult to open, particularlyin an emergency situation where the medicine must be delivered as fastas possible under stressful circumstances.

Another disadvantage with the gelatin capsules is that they may becomebrittle. In this case, the piercing operation may produce shards orfragments that can be inhaled by the patient. In addition, gelatin is amaterial of biological origin and therefore often contains a certainamount of microbiological organisms, leading to possible contaminationof the medicament.

Removal of the capsule from the secondary packaging and loading it intothe device may require a degree of dexterity greater than that possessedby some patients. In addition, the motion of the elongate gelatincapsule within the device may be irregular, leading to incomplete orvariable dispensing of the powdered medicament.

Other dry powder inhaler systems use foil based drug storageconfigurations. These systems also suffer from a variety ofdisadvantages. Many foil-based systems require complex manufacturing andfilling processes. In addition, to open these foil based systems,external puncturing mechanisms, which can cause “dead spots” of trappedmedication, are normally used.

SUMMARY

The present invention meets the foregoing objects by providing a sealeddevice for storing and delivering a substance, such as a medicine. Thesystem and method for storing and delivering a medicine into an air pathincludes a first chamber that constrains the medicine to a particulararea. Part of the first chamber defines at least one boundary of the airpath. The air path is originally sealed but is capable of being openedby a first opening device that is capable of opening at least one airpassage into the air path. This allows dispersion of said medicine intosaid air path. The system further includes a dose metering system thatis integral with the first chamber. The dose metering system may belocated inside the first chamber or it may be part of the wall of thefirst chamber. In some aspects of the invention, the dose meteringsystem may include an air deflection system.

The system may have a moisture impermeable barrier that at leastpartially seals the air path. The first opening device, a second openingdevice or a combination thereof may be used to open an air passage intothe air path. Penetration of the moisture impermeable barrier, ormovement of another part of the system that seals the air path providesthe requisite opening. In some embodiments, the first opening device isinternal to the first chamber. A preferred second opening device is aplunger which may have a cutting edge.

The system may also have a second chamber interior to the first chamber.This second chamber may contain the medicine and this second chamber maybe movable relative to the first chamber. For example, the secondchamber may be movable from a first position to a second position by theaction of a second opening device like a plunger. The second chamber mayinclude access holes that allow dispersion of the medicine into the airpath when the second chamber has moved to the second position.Preferably, the second chamber is constructed such that the access holesare blocked to prevent release of the medicine into the air path whenthe second chamber is in the first position but the access holes areopened when the second chamber is moved to the second position.

The system may also include an obstacle that delineates at least aportion of the air path in conjunction with at least one wall of thefirst chamber. The obstacle may form part of a wall of the secondchamber.

The system may include an active method of assisting in dispersing themedicine into the air path. One active way of assisting in thedispersion is a source of active air flow to assist in dispersing themedicine into the air path. Preferred sources of active air flow are afan and a source of compressed air. When using the active air flowsource, the system may include a mixing chamber, preferably one made ofa flexible material. Alternatively, the system may also include a sourceof vibration to assist in dispersing the medicine into the air path. Thevibration source can cause the second chamber to tumble.

The present invention provides for the integration of drug or medicinedispersion methods into the medicine delivery system. The dispersionmethods used include shear (e.g., air across a drug, with or without agas assist), capillary flow or a venturi effect, mechanical means suchas spinning, vibration, or impaction, and turbulence (e.g., using meshscreens, or restrictions in the air path). These methods of drugdispersion allow for all of the drug in the packaging device to bereleased, allowing control of the dosage size. These methods alsoprovide for drug metering, fluidization, entrainment, deaggragation anddeagglomeration.

The present invention also provides for the integration of a drugsealing system into the medicine delivery system. The drug sealingsystem provides a method of blocking the migration of drug from one areaof the package to another. The drug sealing system can also provide away of tightly containing the drug until the air path in the system isopened, of directing airflow through the package and of managing andcontaining drug during the manufacturing process.

All of the design embodiments of the medicine delivery system can beconfigured for passive or active applications. In particular, variantscan be made on each of the designs that use compressed air, vibration,spinning or the like to assist in dispersing the drug. The discloseddrug package can be integrated into a wide variety of inhalerconfigurations including a single-dose and multi-dose applications ineither active or passive design format. In addition, the conceptsdescribed could also be applied to combination dose configurations andtherapies.

BRIEF DESCRIPTION OF THE DRAWINGS

FIGS. 1A and 1B illustrate a basic variant of the drug or medicinedelivery system of the invention having a sealed air path and a screenor mesh for drug dispersion in open and closed position;

FIGS. 2A and 2B illustrate a drug delivery system such as is shown inFIGS. 1A and 1B in open and closed position but with the addition of aplunger that pierces the seal and activates the internal openingmechanism.

FIGS. 3A and 3B illustrate a drug delivery system with a second chamberin an open and closed position that allows for a venturi effect toassist in drug dispersion;

FIGS. 4A and 4B illustrate a drug delivery system similar to that ofFIGS. 3A and 3B except it includes an active air supply that assists indrug dispersion;

FIGS. 5A and 5B illustrate a drug delivery system similar to that ofFIGS. 3A and 3B except it is designed to allow vibration to assist indrug dispersion;

FIGS. 6A and 6B illustrate a drug delivery system similar to that ofFIGS. 5A and 5B except it includes an active vibration source to assistin drug dispersion;

FIGS. 7A and 7B illustrate a drug delivery system with a second chamberin an open and closed position that allows for tumbling or shaking ofthe second chamber to assist in drug dispersion;

FIGS. 8A and 8B illustrate a drug delivery system similar to that ofFIGS. 7A and 7B except it includes an active air flow source to assistin drug dispersion;

FIGS. 9A and 9B illustrate a drug delivery system with a second chamberin an open and closed position that allows for spinning of the thirdchamber to assist in drug dispersion;

FIGS. 10A and 10B illustrate a drug delivery system similar to that ofFIGS. 9A and 9B except it includes an active air flow source to assistin drug dispersion;

FIGS. 11A and 11B illustrate a drug delivery system that includes aspinning source to assist in drug dispersion;

FIGS. 12A and 12B illustrate a multidose delivery system in an open andclosed position;

FIGS. 13A and 13B illustrate a simple variant of the drug deliverysystem using a shaped geometry to assist in dispersing the drug in theopen and closed positions; and

FIGS. 14A and 14B illustrate a variant of the drug delivery system ofFIGS. 13A and 13B with an integral opening device in addition to theshaped geometry to assist in dispersing the drug in the open and closedpositions.

DETAILED DESCRIPTION

The medicine storage and delivery system of the present inventionprovides an improved package for storing and delivering a medicine. Theenhanced sealing of the device promotes improved delivery of themedicine by providing better protection of the medicine from theelements, particularly if it is in the form of a powder, and improvedopening of the packaging to eliminate “dead spots.” In addition, thepresent invention provides active and passive variants that allow forbetter drug dispersion and improved delivery capabilities.

The following definitions are used throughout the specification and theclaims:

The term “puncturing” refers to any form of opening, including piercing,perforating, peeling and tearing.

The term “internal opening mechanism” or “IOM” refers to a device thatis used to puncture or open at least one portion of a sealed device. TheIOM can take many forms including a tube shape with an annular cutter ateach end, or a sliding internal chamber with a piercing end. Theinternal opening mechanism can act as a structural support to minimizedeformation of the drug package by an external opening device.

The term “drug seal system” “DSS” refers to a component or interactionbetween components that provide a means of blocking the migration ofdrug from one area of the package to another. The drug seal system canalso provide a means of tightly containing the drug until the package isopened, a means of directing airflow through the package and a means ofmanaging and containing drug during the package/device manufacturingprocess. The drug sealing system can vary from a chamber to a flat coverdepending on the package requirements. The DSS can also provide acutting edge for opening the air path, and can be located inside oroutside a moisture barrier. In embodiments where the DSS is locatedoutside the moisture barrier, it could be a part of the inhaler deviceor a separate piece.

The term “dose metering system” or “DMS” refers to a dedicatedcomponent, a specific geometry associated with a component, or theinteraction between two or more components, that is designed tofacilitate drug fluidization and dispersion along the air path throughthe drug package. The DMS can be integrated into the internal openingmechanism, the moisture barrier, the air path, the drug sealing systemor in combination with any of these components, or can be a stand alonecomponent. The DMS can be activated by actuation of the IOM or DSS, canhave a stationary geometry or be a movable component, can be passive oractive, and can utilize aerodynamics, compressed air, vibration orcentrifugal force.

The term “external plunger” or “plunger” refers to a movable componentthat is designed an air passage into the air path to open. The externalplunger can be designed to pierce the seal of the air path from theoutside by means of a cutting protuberance or can be designed to pressthe moisture barrier against an internal cutting protuberance located onthe IOM, DSS, DMS or combination of these. The external plungerminimizes the space required to open the package, can activate thesimultaneous opening of the air path by the IOM and drug sealing system(if applicable) and DMS (if applicable), and can act as a drug seal insome embodiments. Furthermore, the external plunger can be designed toprovide the air inlet into the drug package, through the plunger. Airchannels integrated into the plunger can direct airflow in a mannercritical to emptying drug from the package.

The term “active” refers to use of an external mechanism or force inaddition to the patient's respiration.

The term “passive” refers to the use of the patient's respiration alone.

The term “chamber” refers to an area of the system that includes aportion that encloses a specific area. Chambers can be a number ofshapes depending on the desired fluid dynamic interaction with theairflow Chamber walls can include channels that direct or divert airflowthrough or around the inside or outside of the chamber Chambers can varyin shape from one portion of the chamber to another. Chambers can bemovable or stationary.

The term “reservoir” is a storage area for holding drug. Reservoirs canhave opening(s) that include a shaped geometry that is optimized todirect or divert the flow of air from the air path into, around orthrough the reservoir. The shaped geometry can also facilitate powderfluidization, entrainment, dispersion and deaggregation/deagglomeration.Openings can be symmetrical or asymmetrical and oriented perpendicular,parallel or at some angle to the airflow.

The invention is best described in conjunction with the followingFigures.

FIGS. 1A and 1B show a basic variant of the drug delivery system of theinvention. FIG. 1A shows the device in the closed position and FIG. 1Bshows it in the open position. The drug delivery system includesmoisture barrier 101, internal opening mechanism 102, outlet ring 103(with integral drug sealing system), and dose metering system 104.

Moisture barrier 101 is comprised of two layers of a moisture imperviousmaterial, typically a plastic coated foil. The top and bottom layers offoil are pre-formed to create moisture barrier 101 when attachedtogether. Furthermore, the top and bottom layers have a formed step 108that interfaces with outlet ring 103. Internal opening mechanism 102resides within moisture barrier 101 and is integral with first chamber111. The drug dose resides inside first chamber 111.

First chamber 111 has an air inlet opening and an air outlet opening,which are in close proximity with the moisture barrier 101 when thepackage is assembled. First cutting edge 106 and second cutting edge 107are located proximate to first and second openings in first chamber 111.The dose sealing system consists of outlet ring 103 and base 105. Thedose sealing system provides an annular pressure creating a tight seal112 between internal opening mechanism 102 and moisture barrier 101 atboth of the first chamber 111 openings.

A dose metering system in the form of a mesh screen 104 is integratedinto the first chamber 111.

To open the package and release the drug, pressure is applied to base105, causing base 105 to move toward outer ring 103. This action appliespressure on the formed steps 108 in moisture barrier 101, causingmoisture barrier 101 to slide against internal opening mechanism 102,which pierces moisture barrier at the first and second cutting edge.This opens an air path 109 through first chamber 111. The foil layers ofmoisture barrier 101 deform 110 to allow the relative movement of base105 and outer ring 103.

Air can be drawn through the open first chamber 111, entraining druginto the air stream. Dose metering system 104 prevents the powder fromleaving the package as one large clump and helps fluidize the dose.

FIG. 2 illustrates a drug delivery device substantially similar to thatof FIG. 1 except that the inlet side of the moisture barrier is piercedwith an external piercing device integrated into a plunger.

Moisture barrier 201 is comprised of two layers of a moisture imperviousmaterial, typically a plastic coated foil. The top and bottom layers offoil are pre-formed to create moisture barrier 201 when attachedtogether. Furthermore, the top layer has a formed step 208 thatinterfaces with outlet ring 203. Internal opening mechanism 202 resideswithin moisture barrier 201 and is integral with first chamber 209. Thedrug dose resides inside first chamber 209.

First chamber 209 has multiple openings including air inlet 212 andoutlet 211, which are in close proximity with the moisture barrier 201when the package is assembled. There is a first cutting edge 206 at theoutlet opening 211 in first chamber 209 and a second cutting edge 207integrated into a protuberance on the plunger 205.

The dose sealing system consists of the outlet ring 203, which providesannular pressure creating a tight seal 215 between internal openingmechanism 202 and moisture barrier 201 at first chamber outlet opening211. In this embodiment, the dose sealing system includes externalannular ring (not shown) or interference fit 216 between moisturebarrier 201 and internal opening mechanism 202.

Integrated into first chamber 209 is a dose metering system in the formof a screen 204.

To open the package, plunger 205 is moved toward outlet ring 203, whichcauses the plunger protuberance 207 to pierce moisture barrier 201 atinlet opening 212 proximate to first chamber 209. The plungerprotuberance moves into first chamber 209 until the plunger shoulder 213contacts the internal opening mechanism 202 at the inlet opening edge214. As plunger 205 continues to move towards outlet ring 203, theinternal opening mechanism slides against moisture barrier 201, causingfirst cutting edge 206 to protrude through moisture barrier 201 atoutlet opening 211. Moisture barrier 201 deforms 210 to allow therelative movement of plunger 205 and outlet ring 203.

Air can be drawn through the open first chamber 209, possibly throughplunger 205, entraining drug into the air stream. Drug metering system204 prevents the drug from leaving the package as one large clump andhelps fluidize the dose.

In alternate configurations, the drug metering system may be outside ofthe first chamber, or may not be present in the package.

The drug delivery device shown in FIGS. 1 and 2 can readily be used inactive configurations such as spinning, vibration and forced airflowsource. Spinning the drug delivery device about its long axis wouldserve the purpose of spreading the drug out against the first chamberwalls, creating a large dose surface area to facilitate rapid meteredfluidization. Similarly, vibration from an “Active” source wouldfacilitate drug dispersion. The active vibration source could be apiezo-electric actuator or a motor. The active configurationalternatively could use an active air flow source such as compressed airor a fan. In this case, the entrained dose would likely be captured in amixing chamber before being delivered to the patient. The mixing chambercould be a rigid vessel or a flexible design that inflates during useand collapses for storage.

FIG. 3 illustrates a device similar to that shown in FIG. 2 except thata second chamber has been added to store the drug dose. The secondchamber provides benefits including secure containment of the drug dose,ease of manufacturing and drug filling, and drug metering. The secondchamber can move relative to the first chamber and has an open andclosed position. To open the package, plunger 305 pierces the moisturebarrier and pushes against the second chamber causing it to slide fromthe closed position to the open position. Air flows through the plunger,around and through the second chamber and out the other side of themoisture barrier. Drug is entrained into the air path by venturi effectthrough openings in the second chamber. The airflow through and aroundthe second chamber is managed by air channels formed by the firstchamber and the second chamber. The air channels are shaped to create arestriction at the second chamber openings, increasing the air velocity,and creating the venturi effect.

Moisture barrier 301 is formed of two layers of a moisture imperviousmaterial, typically a plastic coated foil. The top and bottom layers offoil are pre-formed to create moisture barrier 301 when attachedtogether. One layer has a formed step 308 that interfaces with outletring 303.

Internal opening mechanism 302 resides within moisture barrier 301 andcreates first chamber 309. First chamber 309 has openings for air inlet312 and outlet 311. Inlet 312 and outlet 311 are in close proximity withthe moisture barrier 301 when the package is assembled. There is a firstcutting edge 306 at outlet opening 311 in first chamber 309 and secondcutting edge 307 integrated into a protuberance on plunger 305.

Second chamber 316 resides within first chamber 309 and contains thedrug dose. Second chamber has a drug sealing system with openings 304that are covered by interference with the internal opening mechanism 302when the device is stored in its closed position. Second chamber 316 canbe moved relative to first chamber 309 to eliminate the interference atthe openings 304 to create a path between the first and second chambers.Integrated into second chamber 316 is a drug metering system in the formof one or more openings designed to fluidize powder in second chamber316 and facilitate dose entrainment into the air path through firstchamber 309 by venturi effect. Second chamber plug 317 is used to closean opening after filling second chamber 316 with drug duringmanufacturing.

Air channels 318 direct airflow past second chamber openings 304 andthrough the device and are formed into the first chamber 309 and thewalls of second chamber 316. These air channels 318 could also take theform of a nozzle or orifice.

To open the device and release the drug, plunger 305 and outlet ring 303are moved together, causing the protuberance on plunger 305 to piercemoisture barrier 301 at inlet opening 312 to first chamber 309. Theprotuberance on plunger 305 moves into first chamber 309 until plunger305 contacts second chamber 316, causing it to open by movement from theclosed to open position. The protuberance on plunger 305 continues tomove into first chamber 309 until plunger shoulder 313 contacts internalopening mechanism 302 at the inlet opening edge 314. As plunger 305continues to move towards outlet ring 303, internal opening mechanism302 slides against moisture barrier 301, causing first cutting edge 306to protrude through moisture barrier 301 at outlet opening 311. Moisturebarrier 301 deforms 310 to allow the relative movement of plunger 305and outlet ring 303.

Air can be drawn through the open first chamber 309, possibly throughplunger 305, and around and through second chamber 316 to entrain druginto the air stream. Dose metering system 304, embodied by specificopening geometry in second chamber 316, prevents the drug from leavingthe package as one large clump and helps fluidize the dose.

This design could also be applied in a combination dose configurationwhere multiple drugs are delivered to the patient at the same time.Typically, the drugs need to be stored separately from each other andthen combined at the time of inhalation. This can be accomplished bydividing second chamber 316 into multiple cavities, or by includingmultiple second chambers 316 within the device.

FIG. 4 illustrates a device similar to that shown in FIG. 3 , exceptthat the inhaler relies on an “Active” source for the air movementthrough the inhaler instead of the patient's inhaling capability. Toensure proper mixing and aerosolization, it is envisioned that theentrained dose may be captured in a mixing chamber 419 before beingdelivered to the user. A mixing chamber may be required if the activeair source is at a higher pressure or flow rate than would want to bedelivered directly to the user. The active airflow source could becompressed air or a fan. The mixing chamber could be a rigid vessel or aflexible design that inflates during use and collapses for storage. Theairflow may be through, or around, plunger 405. The other parts shown inFIG. 4 are similar to those shown in FIG. 3 .

This design could also be applied in a combination dose configurationwhere multiple drugs are delivered to the patient at the same time.

FIG. 5 illustrates a device similar that shown in FIG. 3 except thatsecond chamber 516 is designed to vibrate to assist in dose metering andevacuation. Second chamber 516 provides benefits including securecontainment of the drug dose, ease of manufacturing and drug filling,and drug metering. Second chamber 516 can move relative to the firstchamber 509. To open the package, plunger 505 pierces moisture barrier501 and pushes against second chamber 516, causing it to slide from theclosed position to the open position. Air flows through plunger 505,around and through second chamber 516 and out the other side of firstchamber 509. Powder is entrained into the air path by vibration causedby the movement of air around second chamber 516. The airflow throughand around second chamber 516 is controlled by air channels formed bythe internal opening mechanism 502 and second chamber 516. Secondchamber 516 may be held in position by a protruding tether that is incontact with internal opening mechanism 502.

Moisture barrier 501 is comprised of two layers of a moisture imperviousmaterial, typically a plastic coated foil. The top and bottom layers offoil are pre-formed to create moisture barrier 501 when attachedtogether. Furthermore, the top layer has a formed step 508 thatinterfaces with outlet ring 503. Internal opening mechanism 502 residesin moisture barrier 501 and creates first chamber 509.

First chamber 509 has openings for air inlet 512 and outlet 511, whichare in close proximity to moisture barrier 501 when the device isassembled. There is a first cutting edge 506 at outlet opening 511 infirst chamber 509 and a second cutting edge 507 integrated into aprotuberance on plunger 505.

Second chamber 516 resides within first chamber 509 and contains thedrug dose. Second chamber 516 contains a drug sealing system includingopenings 504 that are covered by interference fit with the first chamber5099 when the device is in its closed position. Second chamber 516 canbe moved relative to first chamber 509 to eliminate the interference atopenings 504 to open the device and create a path between the first andsecond chambers.

Also integrated into second chamber 516 is a drug metering system in theform of one or more openings designed to fluidize powder in secondchamber 516 and facilitate drug entrainment by vibration and venturieffect into the air path through first chamber 509. Second chamber 516has a protruding section 519 extending toward air path inlet 512 thatattaches to the internal opening mechanism 502. Protruding portion orgeometry 519 is the only point of contact with the internal openingmechanism 502 when second chamber 516 is in the open position.Protruding geometry 519 is shaped to allow second chamber 516 to vibratein response to surrounding airflow turbulence. For example, protrudinggeometry 519 may be a flexible beam (like a tuning fork tine) or aflexible tether (such as a string or chain). Second chamber plug 517 isused to close an opening after filling second chamber 516 with drugduring manufacturing.

To open the device and release the drug, plunger 505 and outlet ring 503are moved together; causing protuberance 507 on plunger 505 to piercemoisture barrier 501 at the inlet opening 512 to first chamber 509.Protuberance 507 on plunger 505 moves into first chamber 509 untilplunger 505 contacts second chamber 516, causing it to open by movementfrom the closed to open position. Protuberance 507 on plunger 505continues to move into first chamber 509 until plunger shoulder 513contacts internal opening mechanism 502 at the inlet opening edge 514.As plunger 505 continues to move towards outlet ring 503, internalopening mechanism 502 slides against moisture barrier 501, causingcutting edge 506 to protrude through moisture barrier 501 at outletopening 511. Moisture barrier 501 deforms 510 to allow the relativemovement of plunger 505 and outlet ring 503.

Air can be drawn through the open first chamber 509, possibly throughplunger 505, and goes around and through second chamber 516, causingsecond chamber 516 to vibrate, and entraining drug into the air stream.Dose metering system 504, formed by the specific opening geometry insecond chamber 516, prevents the powder from leaving the package as onelarge clump and helps fluidize the dose.

This design could also be applied in a combination dose configurationwhere multiple drugs are delivered to the patient at the same time.Typically, the drugs need to be stored separately from each other andthen combined at the time of inhalation. This can be accomplished bydividing second chamber 516 into multiple cavities, or by includingmultiple second chambers 516 within the device.

FIG. 6 is similar to the device described and illustrated in FIG. 5except that the inhaler relies on an “Active” source for vibration ofthe drug dose chamber instead of the patient's inhaling capability toactivate the system. The active vibration source could be apiezo-electric actuator or a motor, possibly integrated with plunger605. The active vibration source can couple to second chamber 616 at theplunger interface, internal opening mechanism 602, or a combination ofthe two. An alternate configuration would be to locate the vibrationsource inside moisture barrier 601. The vibration source could be apiezoelectric material, a specific component geometry that can beexcited at target frequencies and amplitudes, or a magnetically coupledresonance receiver. The internal vibration source could be anindependent component or be fully or partially integrated into internalopening mechanism 602, moisture barrier 601, second chamber 616 or acombination thereof. Electro-mechanical coupling can be accomplished bymeans of plunger 605, which makes contact with the internal vibrationsource after piercing moisture barrier 601. An alternate coupling schemewould allow electro-mechanical contact once the internal vibrationsource moved outside moisture barrier 601 and contacted the deviceduring package opening. Coupling can also be achieved by making anon-physical electrical or magnetic connection with the internalvibration source, such as through inductive coupling.

The active vibration configuration alternatively could use an active airflow source such as compressed air or a fan. In this case, the entraineddose would likely be captured in a mixing chamber (not shown) beforebeing delivered to the patient. The mixing chamber could be a rigidvessel or a flexible design that inflates during use and collapses forstorage. The active airflow through the package could be deliveredthrough the plunger.

This design could also be applied in a combination dose configurationwhere multiple drugs are delivered to the patient at the same time.

FIG. 7 is similar to the device described in conjunction with FIG. 2except that a second chamber has been added to store the drug dose. Thesecond chamber provides benefits including secure containment of thedrug dose, ease of manufacturing and drug filling, and drug meteringinto the air stream. The second chamber can move relative to the firstchamber and has an open and closed position. To open the package, theplunger pierces the moisture barrier and pushes against the secondchamber, causing it to slide from the closed position to the openposition. Air may flow through the plunger, or around it, and possiblythrough the second chamber and out the other side of the moisturebarrier. Powder exits through openings in the second chamber by acombination of tumbling, shaking and spinning, and is entrained into theair path. Powder may also exit the second chamber by venturi effectand/or by air flowing through the second chamber. The airflow around thesecond chamber may be managed by air channels formed by the firstchamber. The air channels could be shaped to create a vortex or spinningof the air within the first chamber to facilitate tumbling and spinningof the second chamber.

Moisture barrier 701 is comprised of two layers of a moisture imperviousmaterial, typically a plastic coated foil. The top and bottom layers offoil are pre-formed to create moisture barrier 701 when attachedtogether. The top layer has a formed step 708 that interfaces withmatching outlet ring geometry 703.

An internal opening mechanism 702 resides in moisture barrier 701 andcreates first chamber 709. First chamber 709 has openings for air inlet712 and outlet 711, which are in close proximity with moisture barrier701 when the device is assembled. There is a first cutting edge 706 atthe outlet opening 711 in first chamber 709 and a second cutting edge707 integrated into a protuberance on the plunger 705.

Second chamber 716 resides within first chamber 709 and contains thedrug dose. Second chamber 716 has a drug sealing system 704 with theopenings in second chamber being covered by interference fit with firstchamber 709 when the device is in its closed position. Second chamber716 can be moved relative to first chamber 709 internal openingmechanism 702 to eliminate the interference at the openings and create apath between the first and second chambers.

Integrated into the second chamber is a drug metering system in the formof one or more openings designed to fluidize powder in second chamber716 and facilitate drug entrainment, primarily by tumbling and spinning,into the air path through first chamber 709. These openings can be atany location in second chamber 716 as required to obtain the desiredfunctionality. Chamber plug 717 is used to close an opening in secondchamber 716 after filling with drug during manufacturing.

To open the package, plunger 705 and outlet ring 703 are moved together,which causes the protuberance on the plunger to pierce moisture barrier701 at the-inlet opening 712 to first chamber 709. Protuberance 707 onplunger 705 moves into first chamber 709 until plunger 705 contactssecond chamber 716 causing it to open by movement from the closed toopen position. Protuberance 707 on plunger 705 continues to move intofirst chamber 709 until plunger shoulder 713 contacts the internalopening mechanism 702 at the inlet opening edge 714. As plunger 705continues to move towards outlet ring 703, internal opening mechanism702 slides against moisture barrier 701, causing cutting edge 706 toprotrude through moisture barrier at outlet opening 711. Moisturebarrier deforms 710 to allow the relative movement of outlet ring 703and internal opening mechanism 702.

Air can be drawn through the open first chamber 709, around and possiblythrough second chamber 716, tumbling or spinning second chamber 716 andentraining drug into the air stream. Mesh screen 719 restrains secondchamber 716 within first chamber 709, and may also prevent the drug fromleaving the package as one large clump.

This design could also be applied in a combination dose configurationwhere multiple drugs are delivered to the patient at the same time.Typically, the drugs need to be stored separately from each other andthen combined at the time of inhalation. This can be accomplished bydividing second chamber 716 into multiple cavities, or by includingmultiple second chambers within the device.

The tumbling chamber drug package configuration can also be utilized inan active inhaler system. FIG. 8 shows this configuration and its use isidentical to that of FIG. 7 , with the difference being that rather thanrelying on the patient's respiration for the air flow to create thetumbling action of second chamber 816, an active compressed air orimpellor system could be used. This may be particularly helpful in caseswhere the patient's airflow rate capabilities are diminished due tomedical conditions. Correspondingly, with an active airflow source, itis envisioned that the entrained dose could be captured in a mixingchamber 820 before being delivered to the user. The mixing chamber couldbe a rigid vessel or a flexible design that inflates during use andcollapses for storage. The airflow through the device can be deliveredthrough, or around, plunger 805.

This design could also be applied to a combination dose configurationwhere multiple drugs are delivered to the patient at the same time.

FIG. 9 illustrates a device similar to the device of FIG. 2 , exceptthat a second chamber 916 has been added to store the drug dose. Secondchamber 916 provides benefits including secure containment of the drugdose, ease of manufacturing and drug filling, and drug metering into theair stream. Second chamber 916 can move relative to internal openingmechanism 902. To open the device, plunger 905 pierces moisture barrier901 and pushes against second chamber 916, causing it to slide from theclosed position to the open position. Air may flow through plunger 905,and around and possibly through second chamber 916 and out the otherside of moisture barrier. Powder exits through openings in secondchamber 916 from the spinning action, and is entrained into the airpath. Powder may also exit second chamber 916 by venturi effect and/orby air flowing through second chamber 916. The airflow around secondchamber 916 may be directed or controlled by air channels formed byfirst chamber 909 internal opening mechanism 902. The air channels couldbe shaped to create a vortex or spinning of the air in first chamber 909to facilitate spinning of second chamber 916.

Moisture barrier 901 is comprised of two layers of a moisture imperviousmaterial, typically a plastic coated foil. The top and bottom layers offoil are pre-formed to create moisture barrier 901 when attachedtogether. Furthermore, the top layer has a formed step 908 thatinterfaces with the geometry of matching outlet ring 903.

Internal opening mechanism 902 resides within moisture barrier 901 andcreates first chamber 909. First chamber 909 has openings for air inlet912 and outlet 911, which are in close proximity with moisture barrier901 when the device is assembled. There is a first cutting edge 906 atoutlet opening 911 in first chamber 909 and a second cutting edge 907integrated into a protuberance on the plunger 905.

Second chamber 916 resides within first chamber 909 and contains thedrug dose. Second chamber 916 has a drug sealing system 904, with theopenings in second chamber 916 being covered by an interference fit withinternal opening mechanism 902 when the device is in its closedposition. Second chamber 916 can be moved relative to internal openingmechanism 902 to eliminate the interference at the openings and create apath between the first and second chambers.

Integrated into second chamber is a drug metering system in the form ofone or more openings designed to fluidize powder in second chamber 916and facilitate drug entrainment, primarily by spinning, into the airpath through first chamber 909. The openings can be in any location onsecond chamber 916. Chamber plug 917 is used to close an opening insecond chamber 916 after filling with drug during manufacturing.

To open the device, plunger 905 is moved toward the outlet ring 903which causes the cutting edge on the plunger protuberance to piercemoisture barrier 901 at inlet opening 912 to first chamber 909. Theprotuberance on plunger 905 moves into the first chamber 909 untilplunger 905 contacts the second chamber 916 causing it to move from theclosed to open position. The protuberance on plunger 905 continues tomove into the first chamber 909 until plunger shoulder 913 contactsinternal opening mechanism 902 at inlet opening edge 914. As plunger 905continues to move towards outlet ring 903, internal opening mechanism902 slides against moisture barrier 901, causing cutting edge 906 toprotrude through moisture barrier 901 at the outlet opening 911.Moisture barrier deforms 910 to allow the relative movement of outletring 903 and internal opening mechanism 902.

Air can be drawn through the open first chamber 909, around and possiblythrough second chamber 916, spinning second chamber 916 and entrainingdrug into the air stream. Air inlets 918 can be configured to create avortex within first chamber 909, which imparts a spinning action onsecond chamber 916. Second chamber 916 may have fins or other geometricdetails that are acted upon by the air to impart the spinning motion.Second chamber 916 is radially supported by first chamber 909 and a meshscreen 919 in order to guide the spinning motion. Mesh screen 919 alsoconstrains second chamber 916 axially within first chamber 909, and mayalso prevent the drug from leaving the package as one large clump.

This design could also be applied in a combination dose configurationwhere multiple drugs are delivered to the patient at the same time.Typically, the drugs need to be stored separately from each other andthen combined at the time of inhalation. This can be accomplished bydividing the second chamber 916 into multiple cavities, or by includingmultiple second chambers within the device.

The spinning chamber drug package configuration can also be utilized inan active inhaler system. FIG. 10 shows this configuration and its useis identical to that of FIG. 9 , with the difference being that ratherthan relying on the patient's respiration for the air flow to create thespinning action of second chamber 1016, an active compressed air orimpellor system could be used. This may be particularly helpful in caseswhere the patient's air flow rate capabilities are diminished due tomedical conditions. Correspondingly, with an active airflow source, itis envisioned that the entrained dose could be captured in a mixingchamber 1020 before being delivered to the user. The mixing chambercould be a rigid vessel or a flexible design that inflates during useand collapses for storage. The airflow through the package can bedelivered through, or around, plunger 1005.

This design could also be applied in a combination dose configurationwhere multiple drugs are delivered to the patient at the same time.

FIG. 11 illustrates a drug delivery device with a movable internalopening mechanism 1102 that contains the drug dose. Internal openingmechanism 1102 is located inside the drug sealing system 1103. Drugsealing system 1103 is located within moisture barrier 1101 and isattached at seal 1114, at least in part, to moisture barrier. Internalopening mechanism 1102 can move relative to moisture barrier 1101 anddrug sealing system 1103. Moisture barrier 1101 is opened when cuttingedge 1105 on internal opening mechanism 1102 is pressed against moisturebarrier 1101. The drug dose exits through an opening 1106 by centrifugalforce as the package is rotated (spinning action) about a main axis ofrotation 1107. In alternate configurations, powder may also exit theinternal opening mechanism by a venturi effect and/or by air flowingthrough internal opening mechanism 1102.

This configuration provides benefits including secure containment of thedrug dose, ease of manufacturing and drug filling, and drug meteringinto the air stream.

Moisture barrier 1101 is comprised of two layers of a moistureimpervious material, typically a plastic coated foil. The top and bottomlayers of foil may be pre-formed to create the moisture barrier 1101when attached together. Drug sealing system 1103 resides within moisturebarrier 1101 and may create a first chamber 1115. The internal openingmechanism 1102 resides within first chamber 1115, and forms secondchamber 1109. The drug dose resides inside second chamber 1109.

Second chamber 1109 has a plugged opening 1104 on one side for drugfilling during manufacturing. The internal opening mechanism has a firstcutting edge 1105 in close proximity to the foil of moisture barrier1101. There is also a seal 1114 between drug sealing system 1103 andmoisture barrier 1101 formed by means of a heat seal or interferencefit. Internal opening mechanism 1102 creates a friction fit seal 1116with drug sealing system 1103 to keep the drug from migrating out ofsecond chamber 1109 prior to use. Drug sealing system 1103 may alsoextend around internal opening mechanism 1102 to guide its motion duringopening of moisture barrier 1101.

To open the device package, internal opening mechanism 1102 is movedrelative to moisture barrier 1101 so that first cutting edge 1105pierces moisture barrier 1101. The motion of internal opening mechanism1102 is caused by spinning the packaging device, creating centrifugalforce which moves internal opening mechanism 1102 away from the axis ofrevolution 1107. In a passive system, the patient's inspiratory airflowwould be used to spin the packaging device. In an active system, thespinning can be accomplished by means of an active spinning source 1108,such as a motor. An active configuration allows for stable control ofrotational speed, and can provide higher opening speeds which allowsthicker, formable foils to be used.

The speed at which piercing occurs can be controlled by a variety offactors, including the mass of internal opening mechanism 1102 andcontained drug, the distance of the center of this mass from the axis ofrevolution 1107, the thickness of the moisture barrier 1101 foil layer,and the geometry of first cutting edge 1105. The ability to dictate thepiercing speed has a number of potential benefits. In a passive system,where the rotation of the packaging device is caused by the patient'sinspiratory air flow, the rotational speed at packaging device openingcan be used to ensure that a minimum inspiratory flow rate is met priorto packaging device opening. In addition, in both passive and activesystems, specific package opening speeds may allow for control of powderdispersion out of second chamber 1109 at predetermined rates.

Following piercing of moisture barrier 1101 by the internal openingmechanism 1102, the drug dose exits second chamber 1109 and is entrainedin the air flow by means of centrifugal force. The rate of drug meteringout of the packaging device can be controlled by means of the geometryof opening 1106 in internal opening mechanism 1102 as well as by thespeed of rotation. It is envisioned that the drug dose may enter amixing chamber 1112 before being delivered to the user. The drug exitsmixing chamber 1112 through outlet mouthpiece 1113.

Piercing of moisture barrier 1101 by internal opening mechanism 1102 canalso be achieved by means of an actuating mechanism 1110 rather thanrelying on centrifugal force caused by spinning of the device. This maybe particularly useful in a passive system where it may be difficult toachieve high rotational speeds using the patient's inspiratory airflowalone.

This design could also be applied to a combination dose configurationwhere multiple drugs are delivered to the patient at the same time.

FIG. 12 illustrates a multi-dose drug delivery device that integratesthe systems illustrated in FIGS. 1-11 and 13-14 and has the benefit ofpackaging multiple doses into a single dispensing system to simplify theuser experience.

The dose packaging is manufactured in strips made up of multiple,factory pre-metered unit-doses 1204 that are positioned in a circulararray and mounted between a two-piece clamshell cassette 1203. The dosepackaging can be color coded to help identify drug type and dosestrength.

The air path through each unit-dose is directed in an outward radialdirection. A plunger 1205 is located at the center of cassette 1203 andhas an outward motion during unit-dose packaging device opening. Amouthpiece 1206 is located on the outside of cassette 1203 and isaligned with the central axis of the first unit-dose 1212. A mouthpiececover 1202 is attached to a mechanism 1213 designed to actuate plunger1205, advance drug cassette 1203 and advance dose counter 1207.

Generally, to operate the multi-dose inhaler the user rotates mouthpiececover 1202 from the closed position 1208 to a first position 1209,exposing mouthpiece 1206. The user then rotates mouthpiece cover 1202 toa second position 1210. This motion 1211 drives plunger 1205 in a radialdirection, opening the unit-dose package 1204 that is aligned withplunger axis 1212. Plunger 1205 may be connected to mouthpiece cover1202 by a mechanical linkage, or, alternatively, there may be a separatemechanism that causes the motion of the plunger that is not tied to themouthpiece cover.

The user inhales to administer the drug dose, and then moves mouthpiececover 1202 back to closed position 1208. The action of closing themouthpiece cover advances unit-dose cassette 1203 to the secondunit-dose position and advances dose counter 1207 by one number.

The multi-dose inhaler design also integrates a dose readinessindicator. The internal opening mechanism inside each dose package canbe color coded for visibility. As each dose package is opened theinternal opening mechanism is exposed and can be made visible to theuser by means of a window in the cassette. Exposed color (green) canindicate that the dose is ready for inhalation.

Dose cassettes 1203 can be designed to be replaceable. In addition, theuser can load cassettes with specific drug dose therapies by opening thecassette and replacing spent doses in a reusable configuration.

FIGS. 13A and 13B show a variant of the drug delivery system of theinvention using a shaped dose metering system to assist in dispersingthe medicine into the air path. FIG. 13A shows the device in the closedposition while FIG. 13B shows it in the open position. The drug deliverysystem includes a first chamber, an opening device, and a dose meteringsystem.

First chamber 1301 is comprised of two layers of material, typically aplastic. The top and bottom layers are pre-formed to create an air path1302 when attached together. A dose metering system 1303 is formed intothe walls of first chamber 1301 to assist in drug dispersion. The drugresides in a reservoir 1304 in proximity to dose metering system 1303when the device is closed and the drug is dispersed into the air pathafter opening the device. Dose metering system 1303 is in the form of ageometry designed to divert, deflect or direct some portion of airflowfrom the first chamber into reservoir 1304. Reservoir 1304 is shaped toreceive airflow diverted from the air path 1302 through first chamber1301, causing the medicine to fluidize and move about reservoir 1304.

First chamber 1301 has air inlet 1305 and air outlet 1306, which areclosed by barriers 1307 when the device is assembled. The airflow ismanaged by air channels formed by the first chamber and the geometryenclosing the air path.

An opening mechanism (not shown) punctures barriers 1307 to open the airpathway 1302. Air can be drawn through open air pathway 1302, andpossibly through the opening mechanism, thereby entraining drug into theair stream. Dose metering system 1303 facilitates fluidization anddispersion of the drug.

Dose metering system 1303 includes a shaped opening 1308. Shaped opening1308 has a geometry designed to control the movement of airflow in, outand around reservoir 1304 as air moves along air path 1302.

The drug delivery device shown in FIGS. 13A and 13B can readily be usedin active configurations such as vibration and forced airflow source.Vibration from an “Active” source would facilitate drug dispersion. Theactive vibration source could be a piezo-electric actuator or a motor.The active configuration alternatively could use an active air flowsource such as compressed air or a fan. In this case, the entrained dosewould likely be captured in a mixing chamber before being delivered tothe patient. The mixing chamber could be a rigid vessel or a flexibledesign that inflates during use and collapses for storage.

This design could also be applied in a combination dose configurationwhere multiple drugs are delivered to the patient at the same time.Typically, the drugs need to be stored separately from each other andthen combined at the time of inhalation. This can be accomplished bydividing reservoir 1304 into multiple cavities, or by including multiplereservoirs 1304 within the device.

FIGS. 14A and 14B illustrate a drug delivery device that is similar tothat of FIG. 13 except that the geometry of opening mechanism 1402defines a portion of first chamber 1403 and air path 1401. Openingmechanism 1402 is movable from a closed position to an open position andis movable relative to reservoir 1404. This configuration providesbenefits including secure containment of the drug. FIG. 14A shows thedevice in the closed position and FIG. 14B shows it in the openposition.

First chamber 1403 is comprised of two parts and typically is made ofplastic. In the illustrated embodiment, opening mechanism 1402 and firstchamber 1403 are pre-formed to create a closed air path 1401. Air path1401 has openings for air inlet 1407 and outlet 1408.

Reservoir 1404 contains the drug dose. Opening mechanism 1402 includes adrug sealing system 1405 that covers the opening to reservoir 1404 byinterference fit when the device is stored in the closed position.Opening mechanism 1402 can be moved relative to reservoir 1404 toeliminate the interference at the opening to create an air path betweenfirst chamber 1403 and reservoir 1404. Integrated into first chamber1403 is a drug metering system 1406 in the form of one or more shapedopenings designed to fluidize powder in reservoir 1404 and facilitatedrug entrainment into air path 1401.

Air path 1401 directs airflow past drug metering system 1406 and throughthe device. The air path can be shaped to create a restriction at thedrug metering system, increasing velocity, and thereby increasing theeffect of drug metering system 1406. Drug metering system 1406 is shapedto divert airflow into, and/or out of reservoir 1404, fluidizing thedrug. Drug is entrained from the reservoir into the airflow by acombination of venturi effect, centrifugal force and turbulence createdat the opening to the reservoir.

To open the device, opening mechanism 1402 is moved from the closedposition to the open position. This action opens air path 1401 throughfirst chamber 1403. This action also moves integral dose sealing system1405 which opens up an air path between first chamber 1403 and reservoir1404.

Air can be drawn through inlet opening 1407, through air path 1401,across drug metering system 1406 and out outlet opening 1408, entrainingdrug into the air stream. Dose metering system 1406, embodied byspecific opening geometry in the reservoir, prevents the powder fromleaving the package as one large clump and helps fluidize the dose.

This design could also be applied in a combination dose configurationwhere multiple drugs are delivered to the patient at the same time.Typically, the drugs need to be stored separately from each other andthen combined at the time of inhalation. This can be accomplished bydividing reservoir 1404 into multiple cavities, or by including multiplereservoirs 1404 within the device.

The drug delivery device shown in FIGS. 14A and 14B can readily be usedin active configurations such as vibration and forced airflow source.Vibration from an “Active” source would facilitate drug dispersion. Theactive vibration source could be a piezo-electric actuator or a motor.The active configuration alternatively could use an active air flowsource such as compressed air or a fan. In this case, the entrained dosewould likely be captured in a mixing chamber before being delivered tothe patient. The mixing chamber could be a rigid vessel or a flexibledesign that inflates during use and collapses for storage.

The system of the present invention provides significant advantages notseen in the prior art. The system provides a sealed, protectedenvironment for a substance and prevents exposure of the substance fromdegrading elements for an extended period of time. For example, thesystem can provide a moisture-impervious environment formoisture-sensitive substances, such as medicines in powdered form. Theuse of an integrated, internal puncturing mechanism (if applicable)facilitates release of the substance from the packaging device withoutrelying on external components. The puncturing mechanism may be easilyactuated, for example, by sliding the puncturing mechanism (i.e., thetube) within the internal chamber of the packaging device or a plungermay be used. The components of the packaging device are designed formanufacturability and the packaging device may be assembled and filledquickly and efficiently. The integrated puncturing mechanism provides aclear, unobstructed path for the substance stored in the packagingdevice to exit and reduces the number of dead spots or edges that trapthe substance, a feature common in capsules that utilize externalpuncturing mechanisms. Moreover, the ability to create an air paththrough an internal chamber of a packaging device allows direct deliveryof the substance, without requiring transfer of the substance to aseparate delivery chamber. The integrated puncturing mechanismfacilitates complete evacuation of all of the substance from thepackaging device interior, resulting in more accurate dosing, increasedsafety and reduced waste.

The present invention has been described relative to illustrativeembodiments. Since certain changes may be made in the aboveconstructions without departing from the scope of the invention, it isintended that all matter contained in the above description or shown inthe accompanying drawings be interpreted as illustrative and not in alimiting sense.

It is also to be understood that the following claims are to cover allgeneric and specific features of the invention described herein, and allstatements of the scope of the invention which, as a matter of language,might be said to fall there between.

1. A dose delivery device, comprising: a lower portion and an upperportion defining a reservoir for containing a dose and including asingle reservoir opening, at least a portion of the reservoir includinga curved surface, and the reservoir being openable, wherein, with thereservoir opened, the lower and upper portions define an air flow pathgenerally along and across at least a portion of an the single reservoiropening of the reservoir from an inlet opening to an outlet opening,such that at least a portion of air in the air flow path enters thereservoir through the single reservoir opening to entrain the dose inthe reservoir, and air including entrained dose exits the reservoirthrough the single reservoir opening and then exits the outlet openingin a direction that is not back toward the inlet opening.
 2. The dosedelivery device of claim 1, further comprising a diverter portionproximate the outlet to divert the at least a portion of air into alower part of the reservoir to disperse the dose in the reservoir intoair flowing into and out of the reservoir.
 3. The dose delivery deviceof claim 2, wherein the diverter portion extends into the air flow pathwith the upper portion in the open position.
 4. The dose delivery deviceof claim 2, wherein the air flow path and the diverter portion arearranged such that a portion of air entering the inlet opening isdiverted into the reservoir and another portion of the air passes to theoutlet opening.
 5. The dose delivery device of claim 1, wherein the airflow path is defined by the lower and upper portions and extends along atop of the lower portion.
 6. The dose delivery device of claim 1,wherein the air flow path includes a restriction to increase air flowvelocity at a location where dose entrained air exits the reservoir. 7.The dose delivery device of claim 6, further comprising a dose in thereservoir.
 8. The dose delivery device of claim 6, wherein the reservoiris arranged such that air exiting the reservoir and entering the airflow path moves in a direction transverse to a portion of air passingfrom the inlet opening to the outlet opening.
 9. The dose deliverydevice of claim 1, further including a mouthpiece for inhaling a dose inthe reservoir.
 10. The dose delivery device of claim 1, wherein theupper portion includes a portion that extends downwardly toward thereservoir.
 11. The dose delivery device of claim 1, wherein the inlet isconfigured to direct at least a portion of the air flow entering theinlet at the outlet.
 12. The dose delivery device of claim 2, whereinthe inlet is configured to direct at least a portion of the air flowentering the inlet at the diverter portion.
 13. The dose delivery deviceof claim 1, wherein the upper portion and the lower portion define anopening mechanism movable from a closed position to an open position.14. The dose delivery device of claim 13, wherein the upper portioncovers an opening to the reservoir when in the closed position.
 15. Thedose delivery device of claim 13, wherein the upper portion slides in alinear direction relative to the lower portion from the closed positionto the open position.
 16. The dose delivery device of claim 1, whereinthe inlet and the outlet are located on opposite sides of the reservoir.17. The dose delivery device of claim 1, wherein the inlet is defined,at least in part, by a surface on the lower portion.
 18. The dosedelivery device of claim 1, wherein the dose is entrained into the airflow path by at least a venturi effect.
 19. An inhaler comprising; areplaceable dose cassette including the dose delivery device of claim 1.